Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-09 @ 5:36 PM
Study NCT ID:
NCT03106051
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2017-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
Long-term Documentation on the Use of Apremilast in Patients With Psoriatic Arthritis in Practice Conditions
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAPIS-PsA
Brief Summary:
A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to 100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's medical section. To increase the quality of the data and to reduce distribution of the data collected, centers to be included will be those which can enroll at least 5 patients. Care will be taken to ensure a balanced regional distribution. The proposed observation period for the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks. The duration of the follow-up period will be extended from approx. 52 weeks to approx. 100 weeks to gain further information about the long-term use of Otezla®. For this extension of the follow-up period 2 new visits (visits 6 and 7) are proposed.Thus, proposed duration from first patient in (FPI) to last patient out (LPO) is 36 months-
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: